U.S. Government urges FDA to speed up new drug applications

The U.S. FDA has been asked by The President’s science advisers to accelerate the approval of new drugs for patients who have high-risk diseases. Concern has been expressed about the length of time taken for the approval process.

The scientists who advise President Obama, The President’s Council of Advisors on Science and Technology (PCAST), have recommended that the U.S. Food and Drug Administration accelerate the process for the approval of drugs for patients who are morbidly obese or who are suffering with so-termed high risk diseases.

According to NIPN, the FDA is often concerned with assessing the side effects of certain medicines. However, the advice from the Presidential advisory panel is that the need of the drug, in relation to patient health, often outweighs the risk of the side effects. Restrictions would be put in place so that the drugs would only be prescribed to people with serious illnesses.

Speaking to the Wall Street Journal, Ellen Sigal, chairwoman of the advocacy group Friends of Cancer Research, said in support of the proposal that the plan would “help deliver promising new medications to patients facing severe illness, while protecting the general public from potential hazards.”

An example would be, according to The Scientist, an individual with morbid obesity may opt to take a drug with more severe side effects than a patient with moderate obesity if that drug is effective at reducing the obesity. However, those with milder obesity could not be prescribed the drug.

It remains to be seen who the FDA will respond to the recommendation and, if they agree, how controls will be put in place to ensure that only the most at risk patients receive drugs of which the side effects have not been fully risk assessed.